CONTRACT RP AND RPI
GDP Consortium have the largest number of eligible RP & RP-I’s in the UK who can assist your business needs.
UK legislation requires any holder of a Human Medicines Wholesale Dealers Authorisation (WDA) to designate a person as a “Responsible Person” (RP). The RP must be suitably qualified and have the appropriate competence and experience as well as relevant knowledge of Good Distribution Practice (GDP).
As of 2023, UK WDA holders importing medicines from EU countries will require the services of an RPi (Responsible Person for Importation).
Having the appropriate RPs & RPi's named on your authorisation is critical to ensure your business operates in a compliant manner and follows regulations accordingly.
GDP Consortium have highly experienced personnel who can act effectively in the RP & RPi role in any size or type of wholesale authorisation holder currently operating in the UK.
As part of our RP service provision we will conduct an initial review of your active or proposed business to establish the required level of RP input to ensure GDP compliance and your public service obligations.
GDP Consortium RP’s/RPi’s would be continuously available once nominated on your WDA. We can also operate as deputy RP’s to provide support to existing or developing company RP’s on an as required or continuous basis.
WDA APPLICATIONS AND LICENSING SUPPORT
If you are looking to set up a business that trades in medicines, we can assist with the set-up of this at every step of the way.
We can help you with navigating through the MHRA application process to ensuring that that the business model you have in mind is suitable and compliant with the associated regulations.
We can provide all the necessary quality documentation that will be tailored precisely to your business and ensure your site is inspection ready.
Audits are a critical part of the GDP compliance process. We can provide a full independent overview of your current practices and their adherence to regulatory standards.
A comprehensive audit report will identify areas of non-compliance and provide an action plan to provide remediation. This will significantly reduce your risk of a poor outcome from your next inspection saving on time, money and reputational damage.
Audits can be undertaken for end to end processes or specific areas of the business and they can also be performed to mirror regulatory inspections.
We can also audit third parties on your behalf to exacting GDP standards as part of your ongoing quality processes and as a critical part of GDP compliance.
We offer an extensive range of both training and development services ranging from group training provision to one-to-one coaching.
Our training is unique in that Peter and Claire have delivered training packages on GDP to Inspectors working for regulators across the globe and are now in the position to provide that expertise to industry.
Training packages can be tailored, and delivery attuned to suit the competence and experience of the audience.
Interactive sessions, discussion of relevant topics amongst delegates and informally with the trainers is encouraged throughout.
We can provide a wide range of training packages covering every aspect of GDP which can be tailored to your specific needs and which can be delivered at your premises or in any suitable venue. This service consists of a preliminary discussion in relation to your specific needs, design of the course material to reflect those, production of materials, delivery of the course, certificate for each delegate and a review with your organisation based on evaluation to further improve or tailor future training provision.
This type can be delivered remotely if required.
As experts in the GDP field, we provide a service where we work with you to review your current training provision and to identify gaps. We provide realistic proposals in terms of tailored solutions. We will analyse your business, interview key personnel and consider any performance management data. We will provide a report identifying areas for improvement and suggesting an appropriate way forward to maximise your training effectiveness.
Focusing on specific areas of development for key personnel within your organisation this can be delivered face to face or remotely. These training sessions can be on any GDP related subject and tailored to an individual or teams needs.
Open Training Courses
Training courses at a number of venues throughout the year will be available. These courses will have set syllabuses and cover such aspects as the RP Gold Standard, Quality Management Systems, transportation considerations, environmental considerations etc which represent good value. You will have the opportunity to mix with people from other organisations and gain the opportunity to share ideas and experience.
GAP ANALYSIS AND REMEDIATION
In the unfortunate event that your company has had an adverse regulatory inspection, we can assist with effective remediation in order to get your business back on track.
Our diverse, multi-skilled team have proven remediation plans that can be tailored and affected as per your organisations needs. For larger projects, we could appoint a dedicated project manager.
Our approach would be to provide a targeted and rapid service to analyse the issues that have been identified and, where necessary, apply practical solutions. To future proof the site, we could design systems to ensure improved compliance that will be acceptable to the regulator.
QUALITY SYSTEM DESIGN
It is a legal requirement that all businesses who hold a Human Medicines Wholesale Dealers Authorisation should operate a fully documented quality management system (QMS). Such a system should set out the responsibilities, processes and risk management principles in relation to the business.
We can create a comprehensive, yet easy to navigate quality system which will be tailored to your individual business needs and meet regulatory requirements of both the Human Medicines Regulations and the Guidelines on Good Distribution Practice of Medicinal Products.
Effective quality management in the GDP arena is important because it prioritises and controls potential hazards in the holding and distribution of medicines. By controlling major risks such as physical contamination or product degradation caused by poor practices the industry can better assure both regulators and consumers that medicinal products are safe.
Additionally, effective application of quality management principles will reduce the potential for both reputational damage and financial risk through improved regulatory compliance.
WAREHOUSE TEMPERATURE MAPPING
We offer a comprehensive temperature and validation service from surveying, planning and placement of temperature and humidity probes, to the analysis and presentation of data.
A comprehensive report is provided for each temperature mapping study.